MAXIMUM STRENGTH BLUE EMU PAIN RELIEF BLU EMU- trolamine salicylate spray

Maximum Strength Blue Emu Pain Relief by

Drug Labeling and Warnings

Maximum Strength Blue Emu Pain Relief by is a Otc medication manufactured, distributed, or labeled by NFI, LLC, Formulated Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Trolamine Salicylate 10%

INDICATIONS & USAGE

Uses

Temporarily relieves pain associated with:  arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

WARNINGS

Warnings

For external use only.  Allergy Alert:  if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.  When using this product:  use only as directed, do not bandage tightly or use with a heating pad, avoid contact with eyes or mucuous membranes, and do not apply to wounds or damaged skin. Stop use and ask doctor if:  condition gets worse, symptoms persist for more than 7 days, or symptoms clear up and occur again in a few days, redness is present, or irritation develops. 

DOSAGE & ADMINISTRATION

Directions

Shake well.  Adults and children 2 years of age and older:  apply to affected area not more than 3 to 4 times daily.  Children under 2 years of age:  ask a doctor.  To apply to face, spray into palm of hand and gently apply.

INACTIVE INGREDIENT

Inactive ingredients

Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Diazolidinyl Urea, Dimethyl Sulfone, Disodium EDTA, DMDM Hydantoin, Emu Oil, Glucosamine Sulfate, Glycerin, Glyceryl Caprylate, Lecithin, Oleic Acid, Panthenol, Phenoxyethanol, Polysorbate 20, Sorbitol, Water, and Xanthan Gum.

PURPOSE

Purpose

Topical analgesic.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH BLUE EMU PAIN RELIEF  BLU EMU
trolamine salicylate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69993-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Trolamine Salicylate (UNII: H8O4040BHD) (Salicylic Acid - UNII:O414PZ4LPZ)	Trolamine Salicylate	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Aloe (UNII: V5VD430YW9)
Caprylyl Glycol (UNII: 00YIU5438U)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
Edetate Disodium (UNII: 7FLD91C86K)
DMDM Hydantoin (UNII: BYR0546TOW)
Emu Oil (UNII: 344821WD61)
Glucosamine Sulfate (UNII: 1FW7WLR731)
Glycerin (UNII: PDC6A3C0OX)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
Oleic Acid (UNII: 2UMI9U37CP)
Panthenol (UNII: WV9CM0O67Z)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polysorbate 20 (UNII: 7T1F30V5YH)
SORBITOL (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)
Xanthan Gum (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69993-100-04	118 mL in 1 CAN; Type 0: Not a Combination Product	06/04/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/04/2012

Labeler - Nutrition & Fitness, Inc., dba NFI Consumer Products, Inc. (016785052)

Establishment
Name	Address	ID/FEI	Business Operations
Formulated Solutions, LLC.		143266687	Manufacture(69993-100)